Flavored gelatin capsule and method of manufacture

ABSTRACT

A flavored gelatin capsule and the method of manufacture of the flavored capsule is provided. The capsule may comprise (a) from about 10 to about 70 parts by weight of gelatin; (b) from about 10 to about 35 parts by weight of a suitable polyol, such as glycerol; (c) from about 8 parts by weight of water; and (c) various parts by weight of particular water soluble flavorings. The contents of the capsule may also be flavored. The composition is particularly useful in improving the palatability of fish oil medicinals.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to capsule formulations, medicinal and nutritivedose encapsulations and methods of manufacture of capsules. Morespecifically, the invention introduces flavoring into the manufacture ofcapsules and encapsulated doses.

2. Conventional Art

The taste of many medicinal and nutritive components can be quitedistinctive and potentially unpleasant. Improvements in the taste ofcertain drugs and nutritional supplements can lead to a highercompliance by consumers. A higher compliance will result in greatercommercial success for the drug and supplement manufacture and inincreased health and well being particular consumers.

Taste is both a matter of purely subjective preference. Yet human tasteis also strongly influenced by experience and cultural impressions.Broad generalizations about consumer taste presence can thus sometimesbe relied upon in predicting market acceptance of specific drug andnutritive formulations. In Norway, for example the tastes of fish oilsare far more palatable than in the United States. As a consequence ofthis United States market aversion to the taste of fish oils, manyresidents of the United States are less willing to ingest fish oils andwill therefore not benefit from the nutritional and medicinal qualitiesof fish oils.

Yet the composition of certain fish oils includes elements that areidentified in medical literature as providing significant healthbenefits. Polyunsaturated fatty acids, to include long chain Omega 3fatty acids such as eicosapentaenoic add (EPA) and docosahexaenoic acid(DHA) are present in the livers of lean fish and other tissues of fattyfish. The human body cannot synthesize these fatty acids nor can itderive them from other fatty acids. As these fatty acids provide bothmedicinal and nutritional benefits, an intake of up two grams per dayhas been recommended by certain medical authorities.

It is suspected that Eicosanoids derived from EPA might have ananti-inflammatory effect on humans. It has been suggested that EPA mightdecrease blood levels of TG lipids, increase blood levels of highdensity lipids (HDL), decrease blood clotting, reduce the incidence ofcardiac arrhythmia and stabilize heart rhythm.

It has been suggested that DHA may also decrease blood levels of TGlipids, increases blood levels of high density lipids (HDL).Furthermore, DHA might lower blood pressure, attack early phases ofinflammation, facilitate the growth, development and function of thecentral nervous system and improves the clinical symptoms of depressionand schizophrenia.

Increasing the consumption of recommended doses of certain Omega-3 fattyacids might therefore have a medically and nutritionally beneficialaffect on many consumers and patients. Yet conventional techniques toimprove the palatability of fish oils and other subjectively harshtasting substances are limited in the prior art to the addition offlavorings into a mixture of the substances themselves. The flavoring ofcapsules of encapsulated formulations has been absent in theconventional art.

OBJECTS OF THE INVENTION

It is therefore an object of the present invention to provide a methodof manufacture of gelatin capsules.

It is another object of the present invention to provide a gelatincapsule comprising a flavor.

It is an additional object of the present invention to optionallyprovide a flavored gelatin capsule containing a fish oil.

It is an yet another object of the present invention to optionallyprovide a flavored gelatin capsule containing a flavored fish oil.

SUMMARY OF THE INVENTION

These and other objects and advantages of the present invention areachieved by providing a flavored gelatin capsule comprising a watersoluble flavor. The flavored gelatin capsule may include about 10 toabout 70 parts by weight of a gelatin, about 10 to about 35 parts byweight of a glycerol, about 8 to about 35 parts by weight of amoisturizer and about 1 parts by weight of the water soluble flavoring.The flavoring of the capsule improves the taste and palatability of thecapsule and will subjectively improve the taste of the gelatin and adose or contents contained within the flavored gelatin capsule toindividual consumers or patients.

The flavor may be one of, or a combination of suitable flavors known inthe art, to include berry, strawberry, chocolate, cocoa, vanilla, lemon,nut, almond, cashew, macadamia nut, coconut, blueberry, blackberry,raspberry, peach, lemon, lime, mint, peppermint, orange, banana, chilipepper, pepper, cinnamon, and pineapple.

The gelatin capsule composition may include a polyol, such as sorbitol,glycerol or other suitable softening agent known in the art.

A preferred embodiment of the present invention includes flavoring thecontents of the gelatin capsule in addition to flavoring the gelatincapsule. In particular, an oil soluble flavoring may be optionally mixedwith a fish oil that is encapsulated within the capsule. The oil solubleflavoring may be similar to the taste of the flavor of the capsule,e.g., strawberry and strawberry, or the taste of the oil flavoring maybe complementary to the capsule flavoring, e.g., banana and strawberry.

Fish oil containing Omega 3 fatty acids such as eicosapetaenoic acid(EPA) and docosahexaenoic acid (DHA) are one appropriate subject ofinclusion into certain preferred embodiments of the present invention asare other digestible oils. The capsule of these certain preferredembodiments is flavored and the fish oil may optionally be flavored.

The method of the present invention includes the manufacturing processsteps of combining gelatin, a glycerol or a ployol like sorbitol as asoftener, water or a moisturizer containing water, a flavoring agent andoptionally a coloring agent such as a titanium oxide, keratin or othersuitable coloring agent known in the art.

Modified vegetable starch is substituted for gelatin in certainpreferred embodiments of the present invention. Where gelatin is used,the gelatin may be a suitable mammalian or fish gelatin known in theart. The suitable gelatin or vegetable starch selected is used as aprincipal forming agent of the capsule.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a flavored gelatin capsule containing a fish oil dose.

FIG. 2 is manufacturing process flow chart illustrating an embodiment ofthe method of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In describing the preferred embodiments, certain terminology will beutilized for the sake of clarity. Such terminology is intended toencompass the recited embodiment, as well as all technical equivalentswhich operate in a similar manner for a similar purpose to achieve asimilar result.

Referring now to FIG. 1, an encapsulated composition of a gelatincapsule and fish oil 2, or fish oil capsule 2, is formed by theencapsulation of a dose of fish oil 6 by a gelatin capsule 4. Thegelatin capsule 4 is made of gelatin, glycerol, water, a flavoring andoptionally a coloring agent. The fish oil dose 6 includes 180 mg of EPAand 120 mg of DHA.

Referring now to FIGS. 1 and 2, the manufacturing process of thepreferred embodiment 2 of includes the steps of combining gelswatchingredients, melting and forming a liquefied gelswatch, delivering theliquefied gelswatch and the fish oil 6 to an encapsulation machine,encapsulating a dose of fish oil, drying the encapsulated dose, washingthe encapsulated dose and packaging the fish oil capsules 2 forshipment.

The gelswatch ingredients may include gelatin or a gelatin substitutesuch as modified starch or other suitable gelatin substitute known inthe art, a softener such as glycerol or sorbitol or other suitablepolyol or other gelatin softener known in the art, a flavoring agentsuch as strawberry flavor Firmenich #52311A or other suitable gelatincapsule flavoring known in the art and optionally a coloring agent suchas keratin or other suitable gelatin capsule coloring agent known in theart.

The preferred embodiment 2 may be formed from a gelswatch mixture of 45parts by weight of gelatin, 20 parts by weight of glycerol, 35 parts byweight of water and 0.5 or more parts by weight of strawberry flavorFirmenich #52311A. The gelswatch ingredients are then heated to about 60degrees to 70 degrees Celsius and mixed together. The capsule is made ofthe gelswatch material. The liquefied gelswatch and the fish oil 6 isthen poured into an encapsulation machine. The encapsulation machinethen forms the fish oil capsule 2 comprising the fish oil dose 6encapsulated by the gelatin capsule 4.

In certain alternate preferred embodiments of the present invention therange of water parts initially combined with the gelswatch may rangefrom about 10 parts by weight to about 45 parts by weight; the amount ofgelatin initially combined into the gelswatch may range from 10 parts byweight to about 70 parts by weight; and the amount of glycerol or othersuitable softener known in the art may range from about 10 parts byweight to about 35 parts by weight.

The capsule composition 2 comprises about 500 milligrams of the fish oildose 6 and about 240 milligrams of capsule 4 as formed from thegelswatch.

The fish oil capsule composition 2 is then dried at a temperature ofabout 20 degrees Celsius. The water content of the gelatin capsule isreduced to about 6% to about 12%, and preferably about 8%+/−2% byevaporation during the drying process step. The capsule 2 is then washedand packaged for shipment.

Experimental testing of the effects of varying amounts of the flavoringin both the capsule 4 and the fish oil 6 has shown that a concentrationof 0.5% in the fish oil 6 of the Firmenich #52311A flavor will degradein less than a year's span to below a desirable level of potency to theaverage North American consumer. Levels of 1 part by weight arepreferred in order to extend the effective shelf life of the composition2 beyond one year.

In addition, stream of commerce testing of concentration levels ofFirmenich #52311A has shown that a level in excess of about 1.0 part byweight of the Firmenich #52311A in the capsule 4 provides an unexpectedincrease in the palatability of the composition 2 by generating aflavored bouquet from the capsules 2, whereby the consumer is greatlyencouraged to ingest the composition 4 in a favorable response to his orher olfactory appreciation of the bouquet.

Certain preferred embodiments comprise fish oil presentingconcentrations of Omega 3 fish as high or higher than 80% of the totalweight of the dose 6, wherein the fish oil may include 50% DHA of thetotal weight of the dose 6, 20% EPA of the total weight of the dose 6and about 10% by weight of other Omega 3 compounds. The concentrationlevels of the flavoring additive of a fish oil dose may, in certainpreferred embodiments of the present invention having about 80% byweight of Omega 3 components, is reduced to from about 0.25% by weightto about 0.50% by weight of the dose 6.

Those skilled in the art will appreciate that various adaptations andmodifications of the just-described preferred embodiments can beconfigured without departing from the scope and spirit of the invention.Therefore, it is to be understood that, within the scope of the appendedclaims, the invention may be practiced other than as specificallydescribed herein.

What is claimed is:
 1. A fish oil capsule for palatable presentation offish oil comprising: a) a gelatin capsule, said gelatin capsulecomprising gelatin, a gelatin softener, water, and a water solubleflavoring, wherein said water is present in said gelatin capsule in aconcentration between about 6% and about 10%, and wherein said watersoluble flavoring is present in a concentration between about 0.50% andabout 1.50% of said gelatin capsule; and b) a fish oil dose, saidgelatin capsule encapsulating said fish oil dose, whereby said fish oilcapsule is a palatable fish oil composition which promotes ingestion ofthe fish oil.
 2. The fish oil capsule claimed in claim 1, wherein saidwater soluble flavoring is present in a concentration between about 0.5%and about 1.0% of said gelatin capsule.
 3. The fish oil capsule claimedin claim 1, wherein said water soluble flavoring is chosen from thegroup consisting of berry, strawberry, chocolate, cocoa, vanilla, lemon,nut, almond, cashew, macadamia nut, coconut, blueberry, blackberry,raspberry, peach, lemon, lime, mint, orange, banana, chili pepper,pepper, cinnamon, and pineapple.
 4. The fish oil capsule claimed inclaim 2, wherein said water soluble flavoring is chosen from the groupconsisting of berry, strawberry, chocolate, cocoa, vanilla, lemon, nut,almond, cashew, macadamia nut, coconut, blueberry, blackberry,raspberry, peach, lemon, lime, mint, orange, banana, chili pepper,pepper, cinnamon, and pineapple.
 5. The fish oil capsule claimed inclaim 3, further comprising an oil soluble flavoring, wherein said oilsoluble flavoring is dissolved in said fish oil dose.
 6. The fish oilcapsule claimed in claim 4, further comprising an oil soluble flavoring,wherein said oil soluble flavoring is dissolved in said fish oil dose.7. The fish oil capsule claimed in claim 5, wherein said oil solubleflavoring is chosen from the group consisting of berry, strawberry,chocolate, cocoa, vanilla, lemon, nut, almond, cashew, macadamia nut,coconut, blueberry, blackberry, raspberry, peach, lemon, lime, mint,orange, banana, chili pepper, pepper, cinnamon, and pineapple.
 8. Thefish oil capsule claimed in claim 6, wherein said oil soluble flavoringis chosen from the group consisting of berry, strawberry, chocolate,cocoa, vanilla, lemon, nut, almond, cashew, macadamia nut, coconut,blueberry, blackberry, raspberry, peach, lemon, lime, mint, orange,banana, chili pepper, pepper, cinnamon, and pineapple.
 9. The fish oilcapsule claimed in claim 7, wherein said oil soluble flavoring ispresent in a concentration between about 0.5% and about 1.0% of saidfish oil dose.
 10. The fish oil capsule claimed in claim 8, wherein saidfish oil dose comprises at least one Omega-3 fatty acid chosen from thegroup consisting of eicosapentanoic acid and docosahexanoic acid. 11.The fish oil capsule claimed in claim 9, wherein said fish oil dosecomprises at least one Omega-3 fatty acid chosen from the groupconsisting of eicosapentanoic acid and docosahexanoic acid.
 12. A fishoil capsule for palatable presentation of fish oil comprising: a) agelatin capsule, said gelatin capsule comprising gelatin, a gelatinsoftener, water, and a water soluble flavoring, wherein said water ispresent in said gelatin capsule in a concentration between about 6% andabout 10%, and said water soluble flavoring is present in said gelatincapsule in a concentration between about 0.25% and about 0.50%, andwherein said gelatin capsule comprises between 10 and 35 percent of saidgelatin softener, and said gelatin softener comprises at least onepolyol, said polyol chosen from the group consisting of glycerol andsorbitol; and b) a fish oil dose, said gelatin capsule encapsulatingsaid fish oil dose, whereby said fish oil capsule is a palatable fishoil composition which promotes ingestion of the fish oil.
 13. The fishoil capsule claimed in claim 12, wherein said fish oil dose has aconcentration of Omega-3 fatty acids above about 80%.
 14. The fish oilcapsule claimed in claim 13, wherein said water soluble flavoring ischosen from the group consisting of berry, strawberry, chocolate, cocoa,vanilla, lemon, nut, almond, cashew, macadamia nut, coconut, blueberry,blackberry, raspberry, peach, lemon, Iime, mint, orange, banana, chilipepper, pepper, cinnamon, and pineapple.
 15. The fish oil capsuleclaimed in claim 14, further comprising an oil soluble flavoring,wherein said oil soluble flavoring is dissolved in said fish oil dose.16. A process for forming a fish oil capsule for palatable presentationof fish oil, comprising the steps of: a) combining gelatin, a gelatinsoftener, water, and a water soluble flavoring; b) forming a gelswatchby heating, melting an mixing said gelatin, said gelatin softener, saidwater and said water soluble flavoring; c) forming a flavored capsulecomprising a gelatin capsule encapsulating a fish oil dose with aportion of said gelswatch; and d) drying said flavored capsule toproduce a water concentration in said gelatin capsule which is betweenabout 6% and about 10%, and a water soluble flavoring concentration insaid gelatin capsule above about 0.25%.
 17. The process described inclaim 16, wherein the water soluble flavoring is present in aconcentration of between about 0.25% and about 1.25% of said gelatincapsule, and wherein an oil soluble flavoring is dissolved in said fishoil dose.
 18. The process described in claim 16, wherein the watersoluble flavoring is present in a concentration of between about 0.25%and about 1.0% of said gelatin capsule, and wherein an oil solubleflavoring is dissolved in said fish oil dose.